MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEONATAL AND PEDIATRIC FLEXTEND; TRACHEOSTOMY TUBE AND TUBE CUFF

Model Number	60PFS35
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while in patient use it was noticed the trach tube had split.It was noticed the patient had increased secretions and were not clearing effectively, it was also noticed the patient looked distressed and puffy eyed.It was then realized the tracheostomy tube had split and had to carry out an emergency tube change.
Additional Manufacturer Narrative
Corrected data: updated description to match customer response.
Event or Problem Description
It was reported that while in patient use it was noticed the trach tube had split.Patient is trach-vented during the day and night.It was noticed the patient did not appear "right" it was described the patient looked puffy eyed and secretions were not clearing when suctioning.It was then noticed a split at the end of the tracheostomy tube (where you connect the swedish nose or ventilator tubing) and an emergency tracheostomy tube change was performed.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Samples were visually inspected under normal conditions of illumination to detect any defect.Under normal conditions of illumination to detect any defect.Cut was found in two samples, complaint was confirmed.The root cause was determined to be manufacturing.Actions were taken to mitigate the reported issue: customer complaint notification was made to production personnel to explain the importance to adherence or following in the manufacturing procedure.

• Brand Name: BIVONA UNCUFFED NEONATAL AND PEDIATRIC FLEXTEND
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14336846
• Report Number: 3012307300-2022-08148
• Device Sequence Number: 20413821
• Product Code: JOH
• UDI-Device Identifier: 15021312005851
• UDI-Public: 15021312005851
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 60PFS35
• Device Catalogue Number: 60PFS35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 04/27/2022; 03/21/2023
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 05/27/2022; 04/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown